Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)

University of Zurich (UZH)

Status: Completed

Conditions: Pulmonary Vascular Disorder; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Arterial Hypertension

Treatments: Other: 6-minute walk distance (6MWD) test on ambient air; Other: 6-minute walk distance test with supplemental oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT06384534

PVD_6MWD_SOT

Details and patient eligibility

About

The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).

Full description

Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design.

The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.

The effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum 18 years of age
• Written informed consent
• Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)
• Former desaturation under exercise defined as Spo2-decrease >3%
• Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion criteria

• Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) < 6.9 Kilopascal (kPa)
• Pregnancy
• Unability or contraindications to undergo the investigated intervention
• Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ambient air

Experimental group

Description:

Patient will perform tests at University Hospital Zurich

Treatment:

Other: 6-minute walk distance (6MWD) test on ambient air

SOT via basal canula

Active Comparator group

Description:

Supplemental Oxygen Therapy (SOT) at approximately 3l/min will be provided via nasal canula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich.

Treatment:

Other: 6-minute walk distance test with supplemental oxygen